The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert, announcing the immediate recall of three batches of substandard antibiotic suspensions manufactured by Sam-Ace Ltd.
The affected products are Astamocil (Amoxicillin Suspension 125mg/5ml) with Batch Number 826024, and Astamentin (Amoxicillin/Clavulanic Acid Suspension) with Batch Numbers 0503024 and 0501724. The recall was initiated after the products failed laboratory analysis during a recent Risk-Based Post-Marketing Surveillance at the Coordinated Wholesale Centre in Kano.
Laboratory investigations revealed that both suspensions contain a low level of the Active Pharmaceutical Ingredient (API), meaning the medicine lacks its full strength and effectiveness.
“This is a critical public health concern,” the agency stated. “Antibiotics with insufficient API can lead to treatment failure, as the medication may not eradicate the infection. This can prolong illness, increase the risk of complications, and potentially contribute to the development of antimicrobial resistance.”
Amoxicillin is a first-line antibiotic commonly prescribed to children for infections of the ear, nose, throat, and respiratory tract. The combination drug, Amoxicillin/Clavulanic Acid, is used for a broader range of bacterial infections.
NAFDAC has directed Sam-Ace Ltd. to recall the identified batches from the market immediately. Healthcare professionals, pharmacists, and patients are urged to check their stock and discontinue the use or sale of these specific batches.
The agency advises anyone who has used these products and has ongoing health concerns to consult their healthcare provider. Members of the public are encouraged to report any suspicion of substandard medicines to the nearest NAFDAC office, via the toll-free line 0800-162-3322, or by email at sf.alert@nafdac.gov.ng.
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